ISRCTN63048529已完成不适用
A multicentre open-label interventional study of patients with medial compartmental knee osteoarthritis (OA) symptoms treated with the KineSpring™ Unicompartmental Knee Arthroplasty (UKA) System
Moximed Inc. (USA)0 个研究点目标入组 40 人开始时间: 2009年7月14日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Aged greater than or equal to 25 years, either sex
- •2. Diagnosis of medial OA of the target knee based on American College of Rheumatology (ACR) Clinical and Radiographic or Clinical Classification criteria for osteoarthritis with a minimum 12 month history
- •3. Continued knee pain despite minimum 3 months of conservative therapy, (i.e., physical therapy, bracing, orthotics, systemic or injected medications)
- •4. Knee flexion greater than or equal to 90 degrees
- •5. KSS knee and function scores less than 70
- •6. Weight greater than 60 kg
- •7. Ability to tolerate antibiotics
- •8. Willing and able to give voluntary written informed consent to participate in this clinical investigation
- •9. Prepared to consent to the transfer of his/her information to third parties
- •10. Willing to undertake the required investigational procedures and willing to return for the required follow-up evaluations
排除标准
- •1. Active infection, sepsis or osteomyelitis, history of infection in the target knee or distant foci of infections which may spread to the implant site
- •2. Rheumatoid arthritis or other forms of inflammatory joint disease
- •3. Significant OA in lateral or patellofemoral compartment
- •4. Previous surgery in the target knee within 12 months prior to screening
- •5. Previous osteotomy or failed knee endoprostheses of any kind in the target knee
- •6. Tibial-femoral varus or valgus alignment greater than 10 degrees
- •7. Ligamentous or meniscal instability as assessed by the Investigator
- •8. Concomitant immunosuppressive therapy
- •9. Paget's disease or metabolic disorders which may impair bone formation
- •10. Osteomalacia or moderate to severe osteoporosis, rapid joint destruction, marked bone loss or bone resorption noted on x-ray
- •11. Charcot's joint disease or other severe neurosensory deficits
- •12. Incomplete or deficient soft tissue surrounding the knee as assessed by the Investigator
- •13. Flexion deformity greater than 10 degrees
- •14. Uncontrolled diabetes mellitus or other significant co-morbidities
- •15. Any significant medical condition (e.g., significant psychiatric or neurological disorders, active alcohol/drug abuse, etc) or other factor (e.g. planned relocation, uncooperative patient) that the Investigator feels would interfere with study participation
- •16. The patient is pregnant or lactating
- •17. Historic or ongoing litigation for or participation in workers compensation for musculoskeletal injuries or disorders
- •18. Subjects who are currently enrolled in another clinical investigation
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